Wirelessly detectable objects for use in medical procedures and methods of making same

ABSTRACT

Various embodiments of a wirelessly detectable object to be used in medical procedures are provided. The object may include a piece of absorbent material, a transponder to wirelessly receive and transmit signals, and a cover. The cover is attached directly to the piece of absorbent material to retain the transponder. Methods of manufacturing wirelessly detectable objects are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit under 35 U.S.C. 119(e) to U.S.provisional patent application Ser. No. 61/109,142, filed Oct. 28, 2008,which is incorporated herein by reference in its entirety.

BACKGROUND

1. Technical Field

This disclosure generally relates to wirelessly detectable objectsuseful in medical procedures such as surgeries, birth deliveries, andother procedures.

2. Description of the Related Art

It is often useful or important to be able to determine the presence orabsence of a foreign object.

For example, it is important to determine whether objects associatedwith a medical procedures, for instance surgery, are present in apatient's body before completion of the medical procedure. Such objectsmay take a variety of forms. For example, the objects may take the formof instruments, for instance scalpels, scissors, forceps, hemostats,and/or clamps. Also for example, the objects may take the form ofrelated accessories and/or disposable objects, for instance surgicalsponges, gauzes, and/or pads. Failure to locate an object before closingthe patient may require additional surgery, and in some instances mayhave serious adverse medical consequences.

Some hospitals have instituted procedures, which include checklists orrequiring multiple counts to be performed to track the use and return ofobjects during surgery. Such a manual approach is inefficient, requiringthe time of highly trained personnel, and is prone to error.

Another approach employs transponders and a wireless interrogation anddetection system. Such an approach employs wireless transponders whichare attached to various objects used during surgery. The interrogationand detection system may include a transmitter that emits pulsedwideband wireless signals (e.g., radio or microwave frequency) and adetector for detecting wireless signals returned by the transponders inresponse to the emitted pulsed wideband signals. Such an automatedsystem may advantageously increase accuracy while reducing the amount oftime required of highly trained and highly compensated personnel.Examples of such an approach are discussed in U.S. Pat. No. 6,026,818,issued Feb. 22, 2000, and U.S. Patent Publication No. US 2004/0250819,published Dec. 16, 2004.

Commercial implementation of such an automated system requires that theoverall system be cost effective and highly accurate. In particular,false negatives must be avoided to ensure that objects are notmistakenly left in the patient. The overall automated system requires alarge number of transponders, since at least one transponder is carried,attached or otherwise coupled to each object which may or will be usedin surgery. Consequently, the transponders and devices for carrying,attaching or coupling the transponder to the object should beinexpensive. In addition, such inexpensive devices must allow accuratedetection and thus not made of metallic materials. Otherwise, if theobject and/or the device carrying the transponder is metallic or othermetallic objects are present in the body, a transponder that is in factpresent may not be able to be detected as a result of the metallicobject acting as a Faraday shield or otherwise interfering withtransponder communications. The transponder and/or device should becapable of undergoing sterilization.

Moreover, transponders are typically attached or otherwise coupled toindividual objects, such as gauzes and lap sponges, one piece of objectat a time. That is, a transponder is attached or otherwise coupled to apiece of gauze or lap sponge from a quantity of individual pieces ofgauzes or lap sponges. In some cases, this may involve unpacking thegauzes or lap sponges from the package they are provided in beforetransponders are individually attached or otherwise coupled to each ofthe gauzes or lap sponges. Further, in certain cases, each piece ofgauze or lap sponge may need to be unfolded first before thecorresponding transponder is attached to it. These additional steps addundesirable time and costs. Consequently, a new inexpensive device forattaching or otherwise coupling a transponder to an object to be used ina medical procedure, and a new method of attaching or coupling suchdevice and transponder to such an object is highly desirable.

BRIEF SUMMARY

At least one embodiment may be summarized as a wirelessly detectableobject for use in medical procedures, which object includes a piece ofabsorbent material, a transponder to wirelessly receive and transmitsignals, and a cover having a receiving cavity to receive thetransponder. The cover may be attached directly to the piece ofabsorbent material to enclose the transponder therebetween. The piece ofabsorbent material may be a sponge. The piece of absorbent material maybe a piece of gauze. The cover may be made of polyvinyl chloride (PVC).

A radio frequency (RF) weld may attach the cover to the piece ofabsorbent material. The detectable surgical object may further includestitching that attaches the cover to the piece of absorbent material.

At least one embodiment may be summarized as a wirelessly detectableobject for use in medical procedures, which object includes a piece ofabsorbent material, a transponder to wirelessly receive and transmitsignals, and a flexible sheet attached directly to the piece ofabsorbent material and forming a pocket to enclose the transpondertherein. The piece of absorbent material may be a sponge. The piece ofabsorbent material may be a piece of gauze. The flexible sheet may be asheet of PVC impregnated cotton fabric. The transponder may be sealed inthe pocket formed by the flexible sheet by RF welding.

An RF weld may seal the transponder in the pocket formed by the flexiblesheet, and stitching that attaches the pocket formed by the flexiblesheet to the piece of absorbent material.

The wirelessly detectable disposable object may be a disposable surgicalobject where the piece of absorbent material has at least one edge andhas a first surface and a second surface opposite to the first surface,wherein the flexible sheet is folded over one of the at least one edgeof the piece of absorbent material to provide a first portion of theflexible sheet adjacent the first surface of the piece of absorbentmaterial and a second portion of the flexible sheet adjacent the secondsurface of the piece of absorbent material, and wherein the firstportion of the flexible sheet is further folded to form the pocketenclosing the transponder therein. The first and the second portions ofthe flexible sheet may be RF welded to the piece of absorbent material.

At least one embodiment may be summarized as a wirelessly detectableobject for use in medical procedures, which object includes a piece ofabsorbent material, a transponder to wirelessly receive and transmitsignals, and a container containing the transponder and attacheddirectly to the piece of absorbent material. The piece of absorbentmaterial may be a sponge. The piece of absorbent material may be a pieceof gauze.

The wirelessly detectable object may further include an RF weld thatattaches the container to the piece of absorbent material. Thewirelessly detectable object may further include a radio-opaque stripcarried by the piece of absorbent material, and the radio-opaque stripmay be a strip of blue barium. The wirelessly detectable object mayfurther include an RF weld that attaches the container directly to theradio-opaque strip. The wirelessly detectable object may further includestitching that attaches the container directly to the radio-opaquestrip.

The wirelessly detectable object may be a disposable surgical objectwhere the container includes first, second, and third members, whereinthe piece of absorbent material has first and second surfaces oppositeto each other, wherein the first member has a cavity to receive thetransponder, wherein the first and second members form a pouch tocontain the transponder, and wherein the pouch containing thetransponder is attached to the first surface of the piece of absorbentmaterial and the third member is attached to the second surface of thepiece of absorbent material directly opposite the pouch. The first,second, and third members of the container may be made of PVC. The pouchand the third member may be attached to the piece of absorbent materialby RF welding.

At least one embodiment may be summarized as a wirelessly detectableobject for use in medical procedures. The medical procedure may, forinstance be a surgical procedure. The object may include a transponderto wirelessly receive and transmit signals, a flexible sheet forming acavity, and at least one RF weld that seals the transponder in thecavity. The flexible sheet may be attached directly to the object. Theobject may include a piece of absorbent material, which may be a sponge.The piece of absorbent material may be a piece of gauze. The flexiblesheet may be made of PVC or may be a piece of PVC impregnated cottonfabric. The flexible sheet may be attached directly to the object by theat least one RF weld.

The wirelessly detectable object may further include stitching thatattaches the flexible sheet directly to the object.

At least one embodiment may be summarized as a method of manufacturing aplurality of wirelessly detectable objects for use in medicalprocedures, including attaching a plurality of transponders to asubstantially flat object; and dividing the substantially flat object toprovide a plurality of discrete objects each having a respective one ofthe plurality of transponders attached thereto. Attaching a plurality oftransponders to a roll of absorbent material may include attaching aplurality of transponders to a roll of gauze. Dividing the roll ofabsorbent material into a plurality of discrete pieces of absorbentmaterial each having a respective one of the plurality of transpondersattached thereto may include dividing the roll of gauze to provide aplurality of discrete pieces of gauze each having a respective one ofthe plurality of transponders attached thereto.

According to at least one embodiment, attaching a plurality oftransponders to a roll of absorbent material may include RF welding aplurality of transponders to the roll of absorbent material.

The method may further include providing a plurality of housing objectseach having a cavity to hold a respective one of the plurality oftransponders, and sealing each of the transponders in the cavity of therespective one of the housing objects by RF welding. Attaching aplurality of transponders to a roll of absorbent material may includeattaching the plurality of housing objects each containing a respectivetransponder to the roll of absorbent material. Providing a plurality ofhousing objects each having a cavity to hold a respective one of theplurality of transponders may include providing a plurality of sheets offlexible material each forming a pocket to hold a respective one of theplurality of transponders. RF welding the housing objects to seal eachof the transponders in the cavity of the respective one of the housingobjects may include RF welding the sheets of flexible material to sealeach of the transponders in the pocket of the respective one of thesheets of flexible material.

According to at least one embodiment, attaching the plurality of housingobjects each containing a respective transponder to the roll ofabsorbent material may include RF welding the plurality of sheets offlexible material each containing a respective transponder to the rollof absorbent material. Attaching the plurality of housing objects eachcontaining a respective transponder to the roll of absorbent materialmay also be sewing the plurality of sheets of flexible material eachcontaining a respective transponder to the roll of absorbent material.Providing a plurality of housing objects may include providing housingobjects made of PVC impregnated cotton fabric or PVC.

The method may further include providing a roll of absorbent materialpouches each containing a respective one of the plurality oftransponders and RF welded to seal the respective transponder within,and separating the roll of absorbent material pouches into individualfabric pouches each containing a respective one of the plurality oftransponders. Attaching a plurality of transponders to a roll ofabsorbent material may include RF welding the fabric pouches to the rollof absorbent material.

The method may further include packaging at least one of the pluralityof discrete pieces of absorbent material having a respective transponderattached thereto. The method may also include testing the at least onepackaged discrete piece of absorbent material having a respectivetransponder attached thereto.

At least one embodiment may be summarized as a method of manufacturing awirelessly detectable object for use in medical procedures, the methodincluding enclosing a transponder in a receiving cavity of a flexibleholder by heat sealing; and attaching the flexible holder to an object.Enclosing a transponder in a receiving cavity of a flexible holder mayinclude enclosing the transponder in the receiving cavity of theflexible holder made of PVC or forming a pocket with a piece of PVCimpregnated cotton fabric to receive the transponder and enclosing thetransponder in the pocket. Enclosing a transponder in a receiving cavityof a flexible holder by heat sealing may include sealing the transponderin the pocket formed from the PVC impregnated cotton fabric by RFwelding, and attaching the flexible holder to a surgical object mayinclude attaching the pocket containing the sealed transponder to theobject by RF welding. Enclosing a transponder in a receiving cavity of aflexible holder by heat sealing may include sealing the transponder inthe pocket formed from the PVC impregnated cotton fabric using RFwelding, and wherein attaching the flexible holder to an objectcomprises attaching the pocket containing the sealed transponder to theobject by sewing.

According to at least one embodiment, attaching the flexible holder toan object may include attaching the flexible holder to a sheet of gauzeor a sponge. Enclosing a transponder in a receiving cavity of a flexibleholder by heat sealing may include sealing the transponder between afirst member of the flexible holder and a second member of the flexibleholder having a receiving cavity to receive the transponder by RFwelding. Attaching the flexible holder to an object may include RFwelding the flexible holder containing the transponder to a radio-opaquestrip on a sheet of lap sponge, which may include RF welding theflexible holder containing the transponder to a strip of blue barium onthe sponge. Attaching the flexible holder to an object may includesewing the flexible holder containing the transponder to a radio-opaquestrip on a sponge. Sewing the flexible holder containing the transponderto a radio-opaque strip on a sheet of lap sponge may include sewing theflexible holder containing the transponder to a strip of blue barium onthe sheet of lap sponge.

According to at least one embodiment, enclosing a transponder in areceiving cavity of a flexible holder may include enclosing each of aplurality of transponders in a respective one of a plurality of fabricpouches, the plurality of fabric pouches being part of a roll of thefabric pouches. Attaching the flexible holder to an object may includeseparating the roll of fabric pouches into individual fabric poucheseach containing a respective one of the plurality of transponders; RFwelding the fabric pouches to a roll of gauze; and separating the rollof gauze into a plurality of individual pieces of gauze each having arespective fabric pouch attached thereto and containing a respectivetransponder.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements as drawn, are notintended to convey any information regarding the actual shape of theparticular elements, and have been solely selected for ease ofrecognition in the drawings.

FIG. 1 is a schematic diagram showing an environment in which medicalprocedures are preformed, for instance a surgical environment,illustrating use of an interrogation and detection system to detect oneor more wireless detectable objects tagged with transponder(s), toprevent the objects from inadvertently being left behind in a patient,according to one illustrated embodiment.

FIG. 2A is a diagram of a transponder device attached to an object to beused in medical procedures, according to one illustrated embodiment.

FIG. 2B is a diagram of a transponder housing that receives and couplesthe transponder to the object, according to one illustrated embodiment.

FIG. 3A is a diagram of a transponder device, according to oneillustrated embodiment.

FIG. 3B is a diagram of a transponder device, according to anotherillustrated embodiment.

FIG. 3C is an isometric view of an assembly of a transponder device andan object to be used in medical procedures, according to one embodiment.

FIG. 3D is a side view of the assembly of an object to be used inmedical procedures with the transponder device attached thereto of FIG.3C.

FIG. 4A is a diagram of a method of attaching a transponder device to anobject to be used in medical procedures, according to one embodiment.

FIG. 4B is a diagram of an object to be used in medical procedures,having a transponder device attached thereto according to the methodshown in FIG. 4A.

FIG. 5A is a diagram of a method of attaching a transponder device to anobject to be used in medical procedures, according to anotherembodiment.

FIG. 5B is a diagram of an object to be used in medical procedureshaving a transponder device attached thereto, according to the methodshown in FIG. 5A.

FIG. 6A is a diagram of a method of attaching a transponder device to anobject to be used in medical procedures, according to yet anotherembodiment.

FIG. 6B is a diagram showing the attachment of a transponder device toan object to be used in medical procedures, according to the methodshown in FIG. 6A.

FIG. 7 is a diagram of a conventional process of manufacturingwirelessly detectable objects to be used in medical procedures.

FIG. 8 is a diagram of a process of manufacturing wirelessly detectableobjects to be used in medical procedures, according to one embodiment.

FIG. 9 is a flow diagram of a method for manufacturing a plurality ofwirelessly detectable objects to be used in medical procedures,according to one embodiment.

FIG. 10 is a flow diagram of a method for manufacturing a wirelesslydetectable object to be used in medical procedures, according to oneembodiment.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various disclosedembodiments. However, one skilled in the relevant art will recognizethat embodiments may be practiced without one or more of these specificdetails, or with other methods, components, materials, etc. In otherinstances, well-known structures associated with transmitters,receivers, or transceivers, and types of objects employed in medicalprocedures, for instance sponges, gauze or other absorbent objects, havenot been shown or described in detail to avoid unnecessarily obscuringdescriptions of the embodiments.

Unless the context requires otherwise, throughout the specification andclaims which follow, the word “comprise” and variations thereof, such as“comprises” and “comprising,” are to be construed in an open, inclusivesense, as “including, but not limited to.”

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment. Thus, the appearances of the phrases “in one embodiment” or“in an embodiment” in various places throughout this specification arenot necessarily all referring to the same embodiment. Furthermore, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more embodiments.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. It should also be noted that the term “or”is generally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

The headings and Abstract of the Disclosure provided herein are forconvenience only and do not interpret the scope or meaning of theembodiments.

For ease of understanding, a surgical environment will be used as anexample environment for detecting objects but such should not beconsidered limiting.

FIG. 1 shows an environment 1 in which medical procedures are performed,for example a surgical environment, clinician's office, examinationroom, patient room or other environments in which medical procedures maybe performed. A medical provider (not shown) operates an interrogationand detection system 5 to ascertain the presence or absence of objectsin, or on, a patient 10.

The interrogation and detection system 5 may include a controller 5 aand an antenna 5 b. The antenna 5 b is coupled to the controller 5 a byone or more communication paths, for example a coaxial cable 5 c. Theantenna 5 b may take the form of a hand-held wand. The controller 5 a isconfigured to cause the antenna to emit wireless interrogation signalsin one or more wide frequency bands, to receive responses fromtransponders to such interrogation signals, and to determine thepresence or absence of a transponder based on the received responses, ifany.

The environment 1 may include a number of objects, collectively 14, usedor employed when performing medical procedures. For instance, theobjects may include surgical objects 14 used in performing surgicalprocedures. The objects 14 may take a variety of forms, for exampleinstruments, accessories and/or disposable objects useful in performingmedical procedures. Each object 14 is tagged, attached, or otherwisecoupled with a transponder device, collectively 20, and thereforedetectable by the interrogation and detection system 5. Thus, medicalprocedure objects 14 a-14 e may each be associated with a respectivetransponder device 20 a-20 e, making those objects 14 wirelesslydetectable.

The transponder devices 20 each include a respective transponder 38. Thetransponder 38 may be constructed in various manners. For example, thetransponder 38 may include a ferrite rod with a conductive coil wrappedabout an exterior surface thereof to form an inductor, and a capacitorcoupled to the conductive coil to form a series circuit. The conductivecoil may, for example, take the form of a spiral wound conductive wirewith an electrically insulative sheath or sleeve. Additional detailsabout types of transponders may be found in U.S. Provisional PatentApplication Ser. No. 60/811,376 filed Jun. 6, 2006 and U.S. ProvisionalPatent Application Ser. No. 60/892,208, filed Feb. 28, 2007.

The transponder 38 is typically small, for example approximately 5-10millimeters long with a diameter of about 1-4 millimeters. In at leastsome embodiments, an encapsulant 30 advantageously protects thetransponder from the ambient environment, for instance from forces,pressure and/or fluids, such as body fluids.

The objects 14 that may be tagged with a respective transponder 38 to bedetectable by the interrogation and detection system 5 may be any typeof object useful in a medical procedures, for instance medicalimplements (e.g., surgical implements) as well as medical supplies oraccessories (e.g., surgical supplies or accessories). Examples ofvarious types of medical implements include, but are not limited to,cutting means (e.g., a scalpel 20 c, lancet, knife, scissors), graspingmeans (e.g., tweezers 14 d, forceps), clamping means (e.g., hemostat 14b, clamps), access means (e.g., dilators, specula, separators),injection/irrigation means (e.g., needles, tips), drilling means (e.g.,a drill bit), or measurement means (e.g., rulers, calipers).

Examples of various types of medical supplies or accessories include,but are not limited to, sponge 14 a and a sheet of absorbent material 14e. The sheet of absorbent material 14 e may be a piece of gauze or apiece of lap sponge, which may be woven or unwoven, for example. Asshown in FIG. 1, the sheet of absorbent material 14 e may be tagged witha transponder device 20 so that the presence or absence of the sheet ofabsorbent material 14 e can be detected by the interrogation anddetection system 5. Again, this helps achieve the goal of avoidingforeign objects, including the sheet of absorbent material 14 e, frombeing unintentionally left at an undesirable location, such as insidethe body of a patient 10, after surgery, child birth or delivery, orother medical procedures.

In use, the medical provider (not shown) may position the antenna 5 bproximate the patient 10 in order to detect the presence or absence ofthe transponder 38 and hence a foreign object. The medical professionalmay in some embodiments move the antenna 5 b along and/or across thebody of the patient 10. In some embodiments, the antenna 5 b may besized to fit at least partially in a body cavity of the patient 10.Different types of transponders 38 may be used. Although a human patient10 is illustrated, the described interrogation and detection system 1may similarly be used on animals.

FIG. 2A illustrates a transponder device 20 e attached to an object 14 eto be used in a medical procedure, according to one embodiment. Sincethe object 14 e may be useful in performing medical procedures, theobject 14 e may be denominated as a medical object or medical procedureobject.

The transponder device 20 e is advantageously attached to a portion ofthe object 14 e such that the transponder device 20 e does notphysically interfere with the operation or use of the object 14 e. Theobject 14 e may be a piece of absorbent material, such as a piece ofgauze or lap sponge. Such objects 14 e are typically disposed of afteruse, so may be denominated as disposable objects, or disposable medicalobjects, or disposable medical procedure objects. Such objects 14 e aretypically considered medical supplies so may be denominated as a medicalsupply or disposable medical supply.

The object 14 e may include a strap or loop 37 to facilitate carrying,moving and/or tactilely locating the object 14 e. The transponder device20 e may comprise an encapsulant or cover 30 and a transponder 38 toretain the transponder 38. The encapsulant or cover 30 may include oneor more structures designed and configured to enclose the transponder 38and directly attach the transponder 38 to a portion of the object 14 e.The encapsulant or cover 30 may be a plastic housing made of polyvinylchloride (PVC). Alternatively, the encapsulant or cover 30 may be madeof PVC impregnated cotton fabric. While the term encapsulant is usedherein, such should not be confused with encapsulants typically used toprovide environmental protection to a circuit or chip. Such encapsulantsare often made of glass or ceramic, and are not typically used todirectly attach a circuit or chip to another structure. As illustratedFIGS. 2B and 3A, such an environmental encapsulant 29 may be used inaddition to the encapsulant or cover 30 discussed herein.

FIG. 2B illustrates the encapsulant 30 of the transponder device 20 eaccording to one embodiment.

The encapsulant or cover 30 may be a PVC cover designed to have areceiving cavity that is sized and shaped appropriately to receive thetransponder 38 such that the transponder 38 fits snugly in the receivingcavity of the encapsulant 30. Alternatively, the encapsulant or cover 30may adapt a different shape and size. For example, the encapsulant orcover 30 may have a dome shape or any other shape. In one embodiment,the encapsulant or cover 30 may be a one-piece cover, and thetransponder 38 may be enclosed between the enclosed space between theencapsulant or cover 30 and the object 14 e when the encapsulant orcover 30 is attached directly to the object 14 e. The encapsulant orcover 30 may be heat sealed to the object 14 e to seal the transponder38 between the encapsulant or cover 30 and the object 14 e. In oneembodiment, the encapsulant or cover 30 may be radio frequency (RF)welded to the object 14 e to seal the transponder 38 between theencapsulant or cover 30 and the object 14 e. Alternatively, theencapsulant or cover 30 may be sewn to the object 14 e by stitching toseal the transponder 38 therebetween.

FIG. 3A illustrates the transponder device 20 e according to oneembodiment.

In this illustrated embodiment, the transponder device 20 e includes acontainer 30 formed from three body portions 30 a, 30 b, and 30 c (FIG.3C). The body portion 30 a may be a cover member made of PVC having adome-shaped cavity in which the transponder 38 may be received. The bodyportion 30 b may be a PVC film sized and shaped to match the outercontour of the body portion 30 a. The body portion 30 c may also be madeof PVC and, like the body portion 30 b, may be sized and shaped to matchthe outer contour of the body portion 30 a. Alternatively, the bodyportions 30 a, 30 b, and 30 c may be made of PVC impregnated cottonfabric.

As shown in FIG. 3A, the transponder 38 is received in the dome-shapedcavity of the body portion or cover 30 a and is enclosed by the bodyportions 30 a and 30 b. Sealing of the transponder 38 within theenclosed space between the body portions 30 a and 30 b may be done by avariety of sealing methods including heat sealing. A type of heatsealing method that may be used is RF welding. Thus, in one embodiment,the transponder 38 may be RF welded within the enclosed space betweenthe body portions 30 a and 30 b. The combination of the body portion 30a, the transponder 38, and the body portion 30 b is labeled as thetransponder pouch 31. In some embodiments, formation of the transponderpouch 31 (i.e., sealing the transponder 38 between the body portions 30a and 30 b) may be done in advance. More specifically, transponderpouches 31 may be made available prior to further manufacturing processis undertaken to the wirelessly detectable objects from the objects 14 eand the transponder devices 20 e.

FIG. 3B illustrates the transponder device 20 e according to anotherembodiment.

Rather than being discretely made from the assembly of individualcomponents, the transponder pouch 31 may come as a roll of transponderpouches 31 each containing a respective transponder 38, as shown in FIG.3B. The roll of transponder pouches 31 may be made by RF welding a rollof fabric laminate 32 a to a roll of PVC film 32 b where a series ofcavities for receiving a corresponding transponder 38 is made byproviding bulges in the roll of fabric laminate 32 a. The fabriclaminate 32 a may be made of PVC or PVC impregnated cotton fabric.Having the transponder pouches 31 come in a roll enhances the efficiencyin the manufacturing process, as all that remains to be done is cuttingor separating the transponder pouches from the roll and attaching eachof the transponder pouches to a respective object 14 e.

FIG. 3C illustrates an isometric view of the assembly of the transponderdevice 20 e and object 14 e to be used in medical procedures, accordingto one embodiment.

As shown in FIG. 3C, the transponder pouch 31, whether assembledindividually with body portions 30 a and 30 b or provided as part of aroll of transponder pouches, may be RF welded to a surface of the object14 e. The body portion 30 c is placed on the other surface of the object14 e directly opposite the transponder pouch 31 so that the transponderdevice 20 e can be RF welded to the object 14 e.

FIG. 3D illustrates a side view of the disposable object 14 e to be usedin medical procedures with the transponder device 20 e attached thereto,according to one embodiment.

FIG. 4A illustrates a method of attaching the transponder device 20 e tothe object 14 e to be used in medical procedures, according to oneembodiment.

The encapsulant or cover 30 of the transponder device 20 e in thisembodiment may be a flexible sheet 33 made from a piece of PVCimpregnated cotton fabric. Thus, the transponder device 20 e in thisembodiment includes the transponder 38 and the flexible sheet 33. Asshown in FIG. 4A, the flexible sheet 33 is folded to form a pouch havinga pocket 34 to receive the transponder 38, and the transponder 38 isenclosed in the pocket 34. The transponder 38 is sealed in the pocket 34by heat sealing, e.g., RF welding, around at least three sides of thetransponder 38. That is, as shown in FIG. 4A, because one side of thetransponder 38 is adjacent the fold in the flexible sheet 33, RF weldingis used to seal the remaining three sides of the transponder 38.

The transponder device 20 e may be attached to the object 14 e, such asa piece of gauze or lap sponge, by sewing. For example, the transponderdevice 20 e may be sewn to the object 14 e by stitching in oneembodiment. To prevent the transponder device 20 e from dangling, e.g.,when the object 14 with the transponder device 20 e attached is held upin such a fashion that the transponder device 20 e is facing downward,at least two lines of stitches are used to attach the transponder device20 e to the object 14 e. The two lines of stitches may be perpendicularto the fold line where the flexible sheet 33 is folded to form thepocket 34. Alternatively, three lines of stitches may be used, as shownin FIG. 4A, to ensure the pouch formed by the folded flexible sheet 33does not dangle. In such case, two of the lines of stitches may beperpendicular to the fold line while the third line of stitches may beparallel to the fold line, as shown in FIG. 4A. In other embodiments,the transponder device 20 e may be attached to the object 14 e by heatsealing, such as RF welding, or other suitable methods.

FIG. 4B illustrates the object 14 e to be used in medical procedureshaving the transponder device 20 e attached thereto, according to themethod shown in FIG. 4A.

FIG. 5A illustrates a method of attaching the transponder device 20 e tothe object 14 e to be used in medical procedures, according to anotherembodiment.

The encapsulant or cover 30 of the transponder device 20 e in thisembodiment may be a flexible sheet 33 made from a piece of PVCimpregnated cotton fabric. Similar to the transponder device 20 e shownin FIG. 4A, the transponder device 20 e in this embodiment includes thetransponder 38 and the flexible sheet 33. As shown in FIG. 5A, theflexible sheet 33 is folded to form a pouch having a pocket 34 toreceive the transponder 38, and the transponder 38 is enclosed in thepocket 34. The transponder 38 is sealed in the pocket 34 by heatsealing, e.g., RF welding, around at least three sides of thetransponder 38. That is, as shown in FIG. 4A, because one side of thetransponder 38 is adjacent the fold in the flexible sheet 33, RF weldingis used to seal the remaining three sides of the transponder 38.

The flexible sheet 33 is further folded to wrap around an edge of theobject 14 e. More specifically, the size and dimension of the flexiblesheet 33 are chosen so that after a first fold (fold 1 shown in FIG. 5A)to form the pocket 34 and a second fold (fold 2 shown in FIG. 5A) towrap around an edge of the object 14 e, the distal end of the flexiblesheet 33 is approximately aligned with the first fold, or fold 1. Inother words, in this embodiment, the flexible sheet 33 is folded toenclose the transponder 38 as well as to “clamp on” an edge of theobject 14 e, which may be a piece of gauze of lap sponge. To secure thetransponder device 20 e to the object 14 e, RF welding may be used, asshown in FIG. 5A. Alternatively, the transponder device 20 e may beattached to the object 14 e by other means including sewing and otherheat sealing methods.

FIG. 5B illustrates the object 14 e to be used in medical procedureshaving the transponder device 20 e attached thereto, according to themethod shown in FIG. 5A.

FIG. 6A illustrates a method of attaching the transponder device 20 e tothe object 14 e to be used in medical procedures, according to yetanother embodiment.

The encapsulant or cover 30 of the transponder device 20 e in thisembodiment may include a top portion 35 a and a bottom portion 35 b eachmade from PVC. Thus, the transponder device 20 e in this embodimentincludes the transponder 38 and the top and bottom portions 35 a and 35b. The top portion 35 a may be designed and shaped to include areceiving cavity to receive the transponder 38. The bottom portion 35 bmay be relatively flat and longer than the top portion 35 a in at leastone dimension to provide for a “tab” portion to allow the transponderdevice 20 e to be attached to the object 14 e to be used in medicalprocedures. As shown in FIG. 6A, the transponder 38 is enclosed betweenthe top portion 35 a and the bottom portion 35 b. As shown in FIG. 6B,the transponder 38 may be sealed in the enclosed space between the topand bottom portions 35 a and 35 b by RF welding or other heat sealingmethod.

The object 14 e may include a radio-opaque strip 36, such as a strip ofblue barium or PVC material, to which the transponder device 20 e may beattached. The object 14 e may further include a strap 37 for ease ofcarrying by a user. The object 14 e may be a lap sponge, for example, oranother type of absorbent material such as gauze, which is typicallydisposed of after use.

FIG. 6B illustrates the attachment of the transponder device 20 e to theobject 14 e to be used in medical procedures, according to theembodiment as shown in FIG. 6A.

As previously described, the transponder device 20 e may have a “tab”given the difference in size and dimension between the top portion 35 aand the bottom portion 35 b. Consequently, the transponder device 20 emay be attached to the radio-opaque strip 36 of the object 14 e bystitching or heat sealing, such as RF welding, or both.

FIG. 7 illustrates a conventional process of manufacturing wirelesslydetectable objects for use in medical procedures, such as pieces ofgauze 14 e each with a transponder device 20 e attached thereto.

The process begins with passing a roll of gauze through a gauze cutterthat cuts the roll of gauze into a plurality of discrete pieces of cutgauze 14 e at 71. The discrete pieces of cut gauze 14 e may be foldedand piled into one or more stacks of gauze at 72 for further processing.For example, the pieces of cut gauze 14 e may be transported to anotherlocation in the factory where the roll of gauze was cut or anotherfactory or geographic location. Folding the pieces of cut gauze 14 e mayrender the transportation of the pieces of cut gauze 14 e easier thanotherwise. Next, at 73, each piece of the cut gauze 14 e may need to beunfolded to allow a transponder to be attached thereto. A transponderdevice 20 e may be attached to a respective piece of cut gauze 14 e bysewing the transponder device 20 e in a patch at 74. Afterwards, thepieces of cut gauze 14 e may be refolded at 75 for packaging at 76. Witha transponder device 20 e attached, each piece of cut gauze 14 e becomesa wirelessly detectable object for use in medical procedures. Thewirelessly detectable objects may be tested for operability at 77 beforethey are sold, distributed, or used.

FIG. 8 illustrates a process of manufacturing wirelessly detectableobjects for use in medical procedures, such as pieces of gauze 14 e eachwith a transponder device 20 e attached thereto, according to oneembodiment.

The process may begin with passing a roll of gauze through an attachingmechanism at 81 that attaches a plurality of transponder devices 20 e tothe roll of gauze. The attaching mechanism may attach the transponderdevices 20 e to the roll of gauze by heat sealing, such as RF welding,or sewing. In any case, the plurality of transponder devices 20 e areattached to the roll of gauze before the roll of gauze is cut intodiscrete pieces of cut gauze by the gauze cutter at 82. After the rollof gauze is cut into discrete pieces of cut gauze 14 e each having arespective transponder device 20 e attached thereto, the pieces of cutgauze 14 e may be folded and stacked into a pile or piles for furtherprocessing. With a transponder device 20 e attached, each piece of cutgauze becomes a wirelessly detectable object. Additional processing mayinclude packaging of the wirelessly detectable objects at 84 and/ortesting the wirelessly detectable objects for operability at 85.

Attaching the transponder devices 20 e to the roll of gauze before theroll of gauze is cut into discrete pieces of cut gauze 14 eadvantageously improves the efficiency associated with manufacturing ofthe wirelessly detectable objects, in terms of time and cost. Comparedwith the conventional process as shown in FIG. 7, the manufacturingprocess shown in FIG. 8 eliminates at least the unfolding and refoldingof the pieces of cut gauze 14 e. Furthermore, because the transponderdevices 20 e are attached to the roll of gauze, rather than beingattached to discrete pieces of cut gauze 14 e individually, theattachment may be done in a serial fashion that may advantageouslyspeeds up the process and thus saves time and cost.

A batch of transponder devices 20 e may be assembled and ready forattachment prior to the process shown in FIG. 8 begins. The transponderdevices 20 e may be provided as a batch of individual transponderpouches 31, as shown in FIG. 3A, or as a roll of transponder pouches 31,as shown in FIG. 3B, for example.

FIG. 9 is a flow diagram of a method 90 for manufacturing a plurality ofwirelessly detectable objects for use in medical procedures, accordingto one embodiment.

The method 90 begins at 92, where a plurality of transponders, such astransponder devices 20 e, is attached to a roll of absorbent material.The roll of absorbent material may be a roll of gauze, for example. Theroll of absorbent material is divided at 94 to provide a plurality ofdiscrete pieces of absorbent material, each of which has a respectiveone of the plurality of transponders attached thereto. The manufacturingmethod 90 may end here as the discrete pieces of absorbent material,each having a respective transponder, can now be considered wirelesslydetectable objects to be used in medical procedures. The method 90 mayadditionally include packaging one or more of the plurality of discretepieces of absorbent material at 96. The method 90 may further includetesting the packaged one or more discrete piece of absorbent materialfor operability at 98.

FIG. 10 is a flow diagram of a method 100 for manufacturing a wirelesslydetectable object for use in medical procedures, according to oneembodiment.

The method 100 begins with enclosing a transponder in a receiving cavityof a flexible holder by heat sealing at 102. RF welding may be theparticular heat sealing method employed. Once the transponder isenclosed in the flexible holder, the flexible holder containing thetransponder is attached to a surgical object at 104. The surgical objectmay be the surgical object 14 e, such as a piece of gauze or lap sponge,for example.

The above description of illustrated embodiments, including what isdescribed in the Abstract, is not intended to be exhaustive or to limitthe various embodiments to the precise forms disclosed. Althoughspecific embodiments of and examples are described herein forillustrative purposes, various equivalent modifications can be madewithout departing from the spirit and scope of the disclosure, as willbe recognized by those skilled in the relevant art.

The teachings provided herein can be applied to other absorbentmaterials, other types of transponders, and other interrogation anddetection systems. For instance, the transponder device may be used tomark objects anytime detection of the presence of marked objects isdesirable in a confined area, not just during surgery. For example, itmay be used to make sure marked objects are not left inside a machine(e.g., vehicle, copy machine) after maintenance is performed. In atleast some embodiments, the transponder housing may be utilized to markobjects to determine the removal of a marked object from a confinedarea, such as a cover-all garment from a clean room of a semiconductorfabrication plant. In such an embodiment, an interrogation device, forexample, may be placed proximate to a door of the confined area.

In addition, a transponder housing or cover may be manufactured anddistributed for tagging objects without a transponder currentlyattached. Advantageously, the housing can then be used to place atransponder compatible with a particular detection and interrogationsystem at a subsequent time, including by the end-user.

The various embodiments described above can be combined to providefurther embodiments. To the extent that they are not inconsistent withthe specific teachings and definitions herein, all of the commonlyassigned U.S. patents, U.S. patent application publications, U.S. patentapplications referred to in this specification, including but notlimited to U.S. Provisional Patent Application Ser. No. 60/811,376 filedJun. 6, 2006; U.S. Provisional Patent Application Ser. No. 60/892,208,filed Feb. 28, 2007; and U.S. provisional patent application Ser. No.61/109,142 filed Oct. 28, 2008 are incorporated herein by reference, intheir entirety. Aspects of the embodiments can be modified, ifnecessary, to employ systems, circuits and concepts of the variouspatents, applications and publications to provide yet furtherembodiments.

These and other changes can be made in light of the above-detaileddescription. In general, in the following claims, the terms used shouldnot be construed to limit the invention to the specific embodimentsdisclosed in the specification and the claims, but should be construedto include all possible embodiments along with the full scope ofequivalents to which such claims are entitled. Accordingly, theinvention is not limited by the disclosure.

I/We claim:
 1. A wirelessly detectable object for use in medicalprocedures, comprising: a piece of absorbent material; a transponder towirelessly receive and transmit signals, the transponder comprising anenvironmental encapsulant; a pouch that contains the transponder, thepouch comprising a fabric laminate and a film, the piece of absorbentmaterial positioned between at least a portion of the fabric laminateand at least a portion of the film; and a radio frequency (RF) weld thatattaches the fabric laminate to the film and thereby secures the pouchto the piece of absorbent material.
 2. The wirelessly detectable objectof claim 1 wherein the piece of absorbent material comprises at leastone of a sponge or a piece of gauze.
 3. The wirelessly detectable objectof claim 1 wherein the film is made of polyvinyl chloride (PVC).
 4. Awirelessly detectable object for use in medical procedures, comprising:a piece of absorbent material, the piece of absorbent material includinga first surface and a second surface that are separated from each otherby an exposed edge portion, the first surface being opposite to thesecond surface; a transponder to wirelessly receive and transmitsignals; a flexible sheet attached directly to the piece of absorbentmaterial and forming a pocket with the piece of absorbent material toenclose the transponder therein, the flexible sheet folded over aportion of the exposed edge portion of the piece of absorbent materialso as to cover the portion of the exposed edge portion and to provide afirst portion of the flexible sheet adjacent the first surface of thepiece of absorbent material and a second portion of the flexible sheetadjacent the second surface of the piece of absorbent material, thefirst portion of the flexible sheet further folded to form the pocketthat encloses the transponder therein; and a radio frequency (RF) weldthat seals the transponder in the pocket formed by the flexible sheetand the piece of absorbent material.
 5. The wirelessly detectable objectof claim 4 wherein the piece of absorbent material comprises at leastone of a sponge or a piece of gauze.
 6. The wirelessly detectable objectof claim 4 wherein the flexible sheet comprises a sheet of polyvinylchloride (PVC) impregnated fabric.
 7. The wirelessly detectable objectof claim 4 wherein the first and the second portions of the flexiblesheet are RF welded to the piece of absorbent material.
 8. A wirelesslydetectable object for use in medical procedures, comprising: a piece ofabsorbent material, the piece of absorbent material including a firstsurface and a second surface opposite to the first surface; atransponder to wirelessly receive and transmit signals, the transpondercomprising an environmental encapsulant; a container containing thetransponder and attached directly to the piece of absorbent material,the container including a first member, a second member, and a thirdmember, the first and the second members forming a pouch that containsthe transponder, the pouch containing the transponder positioned on thefirst surface of the piece of absorbent material and the third memberpositioned on the second surface of the piece of absorbent materialdirectly opposite the pouch; and a radio frequency (RF) weld thatattaches the pouch containing the transponder to the third member so asto thereby attach the container to the piece of absorbent material. 9.The wirelessly detectable object of claim 8 wherein the first member,the second member, and the third member of the container are made ofpolyvinyl chloride (PVC).
 10. The wirelessly detectable object of claim8, further comprising: a radio-opaque strip carried by the piece ofabsorbent material.
 11. A wirelessly detectable object for use inmedical procedures, comprising: a piece of absorbent material, the pieceof absorbent material including opposing first and second surfaces; atransponder to wirelessly receive and transmit signals; a containerincluding a first body portion, a second body portion, and a third bodyportion, the first and second body portions defining a cavity thatcontains the transponder, the first, second, and third body portionseach including matching outer body contours; and at least one radiofrequency (RF) weld that seals the first, second, and third bodyportions to the absorbent material by the at least one RF weld with theabsorbent material secured between the second and third body portions.12. The wirelessly detectable object of claim 11 wherein the containercomprises polyvinyl chloride (PVC).